Pfizer, Bristol-Myers Squibb receive FDA CRL for ELIQUIS NDA

Bristol-Myers Squibb .Jun 25 2012

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ELIQUIS^® (apixaban) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.    

The CRL requests additional information on data management and verification from the ARISTOTLE trial. Bristol-Myers Squibb and Pfizer will work closely with the FDA on the appropriate next steps for the ELIQUIS application. The FDA has not requested that the companies complete any new studies. FDA and the companies are committed to working expeditiously to address the outstanding questions and move the application forward.

"There is a significant unmet need to reduce the risk of stroke in patients with atrial fibrillation," said Elliott Sigal, M.D., Ph.D., Executive Vice President and Chief Scientific Officer, Bristol-Myers Squibb. "We believe that the two large trials called ARISTOTLE and AVERROES have established the therapeutic profile for ELIQUIS and demonstrated a meaningful advance over the standard of care."

The companies continue to progress the ELIQUIS application for stroke prevention in atrial fibrillation in markets outside of the U.S., including the European Union and Japan, based on the ARISTOTLE and AVERROES studies. These studies evaluated ELIQUIS in approximately 24,000 patients with atrial fibrillation, including patients who are expected or demonstrated to be unsuitable for vitamin K antagonist (VKA) therapy. The companies are committed to an ongoing clinical development program for ELIQUIS, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind Phase 3 trials.